CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 384 enrolled
Drug / intervention
Online Behavioral Weight Loss Program +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04520256
NCT04520256Phase 3Completed
CompareCT.gov

Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

The Miriam Hospital·interventional·Posted Aug 20, 2020·Updated Jan 15, 2025

In Brief

A Phase 3 clinical trial evaluating Online Behavioral Weight Loss Program, Virtual Reality for Behavioral Weight Loss Skills Training, and 4 other interventions for Overweight and Obesity. Completed, enrolled 384 participants across 1 site.

Detailed Summary

When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, after a 12-month online behavioral obesity treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight and Obesity
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 20, 2020
Enrollment StartSep 22, 2020
Primary CompletionMay 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.9 years ago

Interventions

Online Behavioral Weight Loss Programbehavioral

A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.

Virtual Reality for Behavioral Weight Loss Skills Trainingbehavioral

This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.

Tailored Interactive Video Feedbackbehavioral

Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity. Additional videos provide dietary skills training.

Tailored Intervention for Structured Physical Activitybehavioral

Periodic self-assessment is used to guide selection of a physical activity goal. Home-based instructional videos are provided to help meet the selected goal.

Skills Training for Dysregulated Eatingbehavioral

Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).

Platform for Social Support & Friendly Competitionbehavioral

An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.